Actively Recruiting
A Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-06
28
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design. Eligible patients with oligometastatic esophageal squamous cell carcinoma were treated with bemosubaiabant, anlotinib, and combined radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabant and anlotinib. During the study period, the subjects were not allowed to receive any other anti-tumor treatments. If the dose of anlotinib hydrochloride was adjusted due to safety events for the subjects, the anlotinib hydrochloride would be dispensed according to the investigator's prescription.
CONDITIONS
Official Title
A Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 years or older
- Diagnosed with oligometastatic esophageal squamous cell carcinoma confirmed by imaging
- No more than 5 metastatic lesions and involvement of up to 2 distant organs, with disease lasting more than 3 months
- At least one measurable lesion according to RECIST 1.1
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function
- For fertile women, must use contraceptive methods from screening to 3 months after treatment and not be breastfeeding
- Negative pregnancy test before starting treatment
- Men must use contraception during the study and for 8 weeks after last dose or have surgical sterilization
You will not qualify if you...
- Previous treatment with PD-1/PD-L1/CTLA-4 antibodies or anti-angiogenic drugs
- Participation in other drug trials within the last 4 weeks or recent anti-tumor therapies
- High risk of bleeding
- History of organ transplantation
- Inoperable conditions
- Severe or uncontrolled diseases including poorly controlled hypertension, significant heart conditions, severe infections, liver cirrhosis, renal failure requiring dialysis, immune deficiency, non-infectious pneumonia or interstitial lung disease, poorly controlled diabetes, significant proteinuria, abnormal coagulation, unresolved toxicities from prior treatments, epilepsy requiring treatment
- Use of systemic corticosteroids over 10 mg/day prednisone equivalent within 7 days before treatment
- Recent live or attenuated vaccine use
- Conditions affecting oral medication intake
- History of substance abuse or mental disorders
- Severe allergic reactions to monoclonal antibodies or investigational drugs
- Investigator judgment deeming unsafe or unable to complete the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
G
Ge Xiao Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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